Non-controlled Trials Research Articles

Research evidence on the management of the cognitive impairment component of the post-COVID condition: a qualitative systematic review.

Cognitive impairment (CI) is one of the most prevalent and burdensome consequences of COVID-19 infection, which can persist up to months or even years after remission of the infection. Current guidelines on post-COVID CI are based on available knowledge on treatments used for improving CI in other conditions. The current review aims to provide an updated overview of the existing evidence on the efficacy of treatments for post-COVID CI. A systematic literature search was conducted for studies published up to December 2023 using three databases (PubMed-Scopus-ProQuest). Controlled and noncontrolled trials, cohort studies, case series, and reports testing interventions on subjects with CI following COVID-19 infection were included. After screening 7790 articles, 29 studies were included. Multidisciplinary approaches, particularly those combining cognitive remediation interventions, physical exercise, and dietary and sleep support, may improve CI and address the different needs of individuals with post-COVID-19 condition. Cognitive remediation interventions can provide a safe, cost-effective option and may be tailored to deficits in specific cognitive domains. Noninvasive brain stimulation techniques and hyperbaric oxygen therapy showed mixed and preliminary results. Evidence for other interventions, including pharmacological ones, remains sparse. Challenges in interpreting existing evidence include heterogeneity in study designs, assessment tools, and recruitment criteria; lack of long-term follow-up; and under-characterization of samples in relation to confounding factors. Further research, grounded on shared definitions of the post-COVID condition and on the accurate assessment of COVID-related CI, in well-defined study samples and with longer follow-ups, is crucial to address this significant unmet need.

Critical Appraisal of Clinical Trials Evaluating Physical Therapy Treatments for Temporomandibular Disorders: AScoping Review.

Physical therapy seems the most promising treatment for temporomandibular disorders (TMD), although their effectiveness is controversial in general, due to high heterogeneity regarding study designs, applied treatments and outcomes measures. The aim of this scoping review is to analyse the methodological characteristics of clinical trials evaluating physical therapy treatments in subjects with TMD. A systematic search was conducted in Medline/PubMed, SPORTDiscus, Scopus, Web of Science, SciELO, Cochrane, ScienceDirect and EMBASE databases on 31 October 2023. Clinical trials evaluating physical therapy interventions in patients older than 18 years with TMD, published in English or Spanish languages. Data regarding content reporting of study designs, sample characteristics, interventions and outcome measures was extracted. Descriptive summary statistics were reported. The search retrieved 15 322 records, and 136 were included. There were 107 randomised clinical trials, 5 non-randomised controlled trials and 24 non-controlled trials. Most studies had moderate to high risk of bias, small sample sizes (median, 44 subjects) and short follow-up periods (1-3 months). The most common diagnostic criteria used was the Research Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD) (48.9%). The most reported experimental interventions were manual therapy (40.4%), exercise (30.2%) and electrotherapy modalities (27.2%), and the most common outcome measure domains were pain (83.8%), range of movement (61.8%), disability (45.6%) and mechanosensitivity (29.4%). There was poor content reporting of experimental interventions. Current literature of clinical trials of physical therapy interventions for TMD has moderate to high risk of bias, poor content reporting, small sample size and short-term follow-ups which limit internal and external validity, as well as applicability into clinical practice.

Effectiveness of High-Intensity Circuit Training on Physical Fitness Among Athletes: A Systematic Review of Randomized-Controlled and Non-Controlled Trials

Background and Aim of the Study: The continuous evolution of sports and athletics necessitates innovative training strategies to optimize athletes’ performance and physical fitness. High-Intensity Circuit Training (HICT) has emerged as a time-efficient method that combines high-intensity exercises with minimal rest, targeting various muscle groups to enhance physical fitness components. Therefore, this systematic review aims to evaluate the effectiveness of HICT on physical fitness components among athletes to provide a clear, evidence-based understanding of HICT’s benefits and limitations. Material and Methods: A comprehensive search strategy was employed, retrieving articles published before September 24, 2023, from databases including the Cochrane Central Register of Controlled Trials, PubMed, and Google Scholar. The selection process followed the PRISMA guidelines, focusing on studies that assessed the impact of HICT on athletes’ physical fitness. The quality of included studies was assessed using the PEDro scale, and data synthesis was conducted to summarize findings on various physical fitness components. Results: The review included 13 studies, highlighting HICT’s positive effects on muscle strength, endurance, flexibility, balance, power, body composition, and cardiovascular endurance. Improvements were noted in neuromuscular efficiency, muscle power, coordination, and cardiovascular fitness, which are crucial for athletic performance. However, the review also identified variability in training adaptations and the need for sport-specific exercises to maximize the benefits of HICT for speed and power enhancements. Conclusions: HICT is a versatile and effective training modality that can significantly improve various aspects of athletes’ physical fitness. Incorporating targeted, sport-specific exercises into HICT programs could further optimize performance enhancements. Despite promising findings, the review acknowledges methodological heterogeneity among studies and calls for further research to refine HICT protocols for athletes.

Does mental fatigue affect performance in racket sports? A systematic review

Mental fatigue impairs performance across several sports domains. However, a systematic review on its effects on racket sports performance has been lacking due to the previous scarcity of studies. This review aims to provide a comprehensive review the effects of mental fatigue on racket players’ performance, with a discussion of the underlying mechanisms. A thorough search was conducted across five databases, including Web of Science, PubMed, SCOPUS, SPORTDiscus (via EBSCOhost), and the Psychological and Behavioral Science Collection (via EBSCOhost). The PICOS framework established the inclusion criteria: (1) healthy racket sports players; (2) induction of mental fatigue in both field and laboratory settings; (3) comparison of mental fatigue interventions with a control group (e.g., watching a movie or reading a magazine); (4) assessment of performance outcomes, including physical performance, skilled performance, and perceptual-cognitive performance; and (5) randomized controlled trials (RCTs), non-randomized controlled trials (non-RCTs), and non-randomized non-controlled trials. Mental fatigue manipulation, subjective evaluation, and (neuro)physiological markers were synthesized to support the successful induction of mental fatigue. Performance was categorized into tennis, table tennis, badminton, and padel based on the characteristics of specific racket sports domains. Secondary outcomes, such as the rate perception of effort (RPE) and motivation, were synthesized to explain the mechanisms based on the prominent theory of the Psychobiological model of endurance performance. Six studies revealed that mental fatigue impacts stroke performance in table tennis, affecting speed, accuracy, faults, and only second-serve accuracy in tennis. The response time of psychomotor performance increased in table tennis, padel, and badminton. Meanwhile, mental fatigue increased the RPE and remained unchanged in heart rate, blood glucose, and lactate, consistent with the Psychobiological model of endurance performance. Additionally, attention is suggested as a significant underlying psychobiological factor.

Colchicine-The Divine Medicine against COVID-19.

Colchicine has a number of effects that suggest it may be useful in the treatment of COVID-19. Myeloid cells are a major source of dysregulated inflammation in COVID-19. The hyperactivation of the NLRP3 inflammasome and the subsequent cytokine storm take place precisely inside them and can lead to multiorgan damage and death. NLRP3 inflammasome inhibition has been assessed at micromolar colchicine concentrations which cannot be achieved in serum. However, colchicine has remarkable ability to accumulate intensively in leukocytes, where the cytokine storm is generated. Over 50 observational studies and randomized clinical trials, small randomized non-controlled trials, and retrospective cohort studies were initiated to test its healing effect in vivo, leading to conflicting, rather disappointing results. The WHO gives a "Strong recommendation against" the use of colchicine for COVID-19 treatment. This is because low doses of colchicine are always used, where the concentrations required to inhibit the NLRP3 inflammasome in leukocytes cannot be reached. Considering this, from March 2020, we started the administration of higher doses of colchicine. Our assumption was that a safe increase in colchicine doses to reach micromolar concentrations in leukocytes will result in NLRP3 inflammasome/cytokine storm inhibition. We demonstrated that in 785 inpatients treated with increasing doses of colchicine, mortality fell between two and seven times. Our data, including a large number of COVID-19 outpatients, showed that nearly 100% of the patients treated with this therapeutic regimen escaped hospitalization. In addition, post-COVID-19 symptoms in those treated with colchicine were significantly rarer. As a large number of viruses can overactivate the NLRP3 inflammasome (like seasonal influenza), we are convinced that higher colchicine doses would be useful in these cases as well.

Mindfulness-based interventions for improving mental health of frontline healthcare professionals during the COVID-19 pandemic: a systematic review

BackgroundMindfulness-based interventions (MBIs) appear to be effective for improving the mental health of healthcare professionals (HCPs). However, the effectiveness of MBIs on extreme psychological trauma caused by the coronavirus disease 2019 (COVID-19) pandemic is largely unknown. The aim of this paper was to systematically review empirical studies of MBIs for HCPs carried out during the COVID-19 pandemic, to evaluate them and their effectiveness in different areas of mental health.MethodsThe electronic databases searched were Web of Science, Scopus, PubMed, and PsycINFO. The date when each database was last searched was September 15, 2023. Randomized controlled trials (RCTs), non-randomized controlled trials (NRCTs), and non-randomized non-controlled trials (NRNCTs) focused on MBIs for health care staff who were working in healthcare centers during the COVID-19 pandemic were included. All of them employed standardized measures of mental health. The review followed the best practices and reported using PRISMA guidelines. A data collection form, adapted from the Cochrane handbook for systematic reviews of interventions, was used to extract and synthesize the results. The methods used to assess the risk of bias in the included studies were the Cochrane Risk of Bias Tool and the ROBINS-I Tool.ResultsTwenty-eight studies were included in the systematic review. Overall, the methodological quality of the studies was moderate. The results showed the effectiveness of MBIs in improving levels of stress, mindfulness, and mental well-being. However, no conclusive results were found regarding the effectiveness of MBIs in improving the levels of burnout, anxiety, depression, sleep quality, and resilience of HCPs.ConclusionsThe MBIs for HCPs carried out during the COVID-19 pandemic have mainly contributed to improving stress, mindfulness, and mental well-being at a time of serious health emergency. However, more robust studies at a methodological level would have been desirable.Systematic review registrationPROSPERO CRD42021267621

Efficacy and safety of terlipressin infusion during liver surgery: a protocol for systematic review and meta-analysis

IntroductionLiver disease causes 2 million deaths annually, accounting for 4% of all deaths worldwide. Liver surgery is one of the effective therapeutic options. Bleeding is a major complication during liver...

Durability of the improvement of collagen I and collagen III with the use of oral isotretinoin in the treatment of photoaging.

Oral isotretinoin (ISO) is the drug of choice for the treatment of severe acne. For photoaging treatment, ISO has been proved to be effective in some controlled and noncontrolled trials and is an alternative to topical retinoic acid (RA) therapy, which causes an expected skin irritation. To evaluate and compare the skin remodeling in patients taking ISO 20 mg 3 times a week for 12 weeks and 12 weeks after the end of the treatment to quantify collagen I and collagen III augmentation. Immunohistochemical studies were performed to evaluate the expression of collagen I and collagen III, metalloproteinases (MMPs) -1, -3, -7, -9, -12, and the tissue inhibitor of MMP type-1 (TIMP-1) of the skin of 20 45 to 50-year-old women through morphometry in a semiquantitative method. The inclusion criteria were facial aging 2 and 3 of Glogau's classification, with phototypes between II and V who had not entered menopause. Biopsies of the skin of the left preauricular region were performed at three different times: pre-treatment (T0), end of 12-week treatment (T1), and 12 weeks posttreatment (T2). Collagen fibers I and III increased with statistical significance in T1 (50.7%; P = 0.012) but not in T2 (49.7%), which in turn was higher than in T0 (47.2%) for collagen I and T1 (33.3%; P = 0.002) but not in T2 (32.7%), and also was higher than T0 (32.0%) for collagen III. MMP-9 presented a decreased activity with statistical significance in T1 (P = 0.047) and T2 (P = 0.058). MMP-1 showed a reduction in T2 only (P = 0.015). MMPs -3, -7, -12, and TIMP-1 did not present significant modification in their expressions during or after the treatment. Low-dose ISO is effective in remodeling the extracellular matrix (ECM). This study found that the increase of collagen occurs through the augmentation of both collagen I and collagen III fibers. With originality, it was possible to verify the durability of these fibers for at least 12 weeks. This may be related to the decrease in MMP-9 expression verified at the end of the treatment and 12 weeks posttreatment.

Effects of Virtual Reality in the Rehabilitation of Parkinson's Disease: A Systematic Review.

Parkinson's disease is characterised by the loss of balance and the presence of walking difficulties. The inclusion of rehabilitation therapies to complement pharmacological therapy allows for comprehensive management of the disease. In recent years, virtual reality has been gaining importance in the treatment of neurological diseases and their associated symptoms. Therefore, the objective of this systematic review was to analyse the effectiveness of virtual reality on balance and gait in patients with Parkinson's disease. This study is a systematic review conducted following PRISMA's statements. An electronic search of the literature was carried out in the following databases: PubMed, Cochrane, Dialnet, Scopus, Web of Science, PsycINFO and Science Direct PEDro. The inclusion criteria were controlled and non-controlled clinical trials published in the last 12 years in English or Spanish, in which virtual reality was applied to treat balance and gait impairments in patients with Parkinson's disease. 20 studies were finally included in this review. A total of 480 patients participated in the included studies. All patients were diagnosed with Parkinson's disease. Most of the investigations used the Nintendo Wii + Balance Board or the Microsoft Kinect TM combined with the Kinect Adventures games as a virtual reality device. According to the results of this literature review, virtual reality-based interventions achieve good adherence to treatment, bring innovation and motivation to rehabilitation, and provide feedback as well as cognitive and sensory stimulation in patients with Parkinson's disease. Therefore, virtual reality can be considered an alternative for personalised rehabilitation and for home treatment.

A226 EFFECT OF PHYSICAL ACTIVITY AMONG INDIVIDUALS WITH QUIESCENT OR MILDLY ACTIVE INFLAMMATORY BOWEL DISEASE: A SYSTEMATIC REVIEW

Abstract Background Individuals with quiescent inflammatory bowel diseases (IBD) can continue to have several symptoms. Physical activity (PA) can improve immunological response and psychological health. Purpose We performed a systematic review of trials investigating the safety and efficacy of PA as an adjunct therapy to manage persistent symptoms in quiescent or mildly active IBD. Method We searched for randomised controlled trials (RCTs) and nonrandomised non-controlled trials (non-RCTs) in eight databases, trial registries and conference proceedings, published in English between 2011 and 2021. We focused on trials in adults (>18 years) using any form of PA as an adjunct therapy to medical therapy. Outcomes of interest were health-related quality of life, fatigue, joint pain, abdominal pain, stress, anxiety, and depression. Result(s) From 10,862 retrieved citations, we identified seven RCTs and one non-RCT that met our inclusion criteria. All trials deemed PA safe for individuals with quiescent or mildly active IBD. Clinical heterogeneity was noted among the trials for all outcomes. Six RCTs utilized parallel-group design while one utilized a cross-over design. Seven trials provided partially or fully supervised PA interventions, and one provided no supervision. All trials used different types of PA, which varied between running, resistance training, yoga, and aerobic exercises. The trials used different parameters to measure PA intensity including Peak Power Output, Resistance Intensity Scale for Exercise, percentage of maximum heart rate, ability to talk while running. Heterogeneity was noted in the duration and frequency of PA. Conclusion(s) Even though PA is safe for individuals with quiescent or mildly active IBD, heterogeneity in available trials make it difficult to ascertain precise estimates of treatment effect. This also presents a challenge when determining the specific modes of PA that are beneficial for individuals with quiescent or mildly active IBD. This highlights the need for standardization of the definitions of parameters involved in PA in IBD research. Please acknowledge all funding agencies by checking the applicable boxes below CAG Disclosure of Interest None Declared

A Review of Cytotoxic Effects of Azo Dyes on Brain-subregion

: Azo dyes, as a major group of the synthetic colorants, are added to food products not only to make them aesthetic but also to preserve their appearance. However, the use of azo dyes in food has been banned worldwide due to side effects on human health. The search was conducted using PubMed, Scopus, Web of Science, Europe PMC beta, Science Direct, and Springer database considering all articles published up to 9 July 2021. The inclusion criteria were double-blind, randomized, cohort studies, placebo-controlled trials, case reports, non-controlled trials, and case series. Several studies suggest that azo dyes induce oxidative stress, which subsequently increases the concentration of malondialdehyde and reduces superoxide dismutase (SOD) activity and glutathione (GSH) concentration in brain tissue. Also, results showed the adverse effects of azo dyes on the brain parts such as the prefrontal cortex, cerebellum, and cerebrum which, are accompanied by changes in brain function. It can be concluded that azo dyes with an increase in oxidative stress affect the most important parts of the brain and cause brain dysfunction. This study aimed to evaluate the effects of the food additive azo dyes on brain tissues.

Does cognitive behavioral therapy without pharmacotherapy improve eating disorder remission rates?

Does cognitive behavioral therapy without pharmacotherapy improve eating disorder remission rates?

Physiotherapeutic Approaches in Thumb Carpometacarpal Joint Arthritis for Pain, Function, and Grip Strength

Abstract Thumb carpometacarpal joint osteoarthritis (CMC OA) is a common condition characterized by chronic progressive degeneration of the joint cartilage. Patients present with complaints of pain at the base of the thumb, morning stiffness, and muscle weakness, all of which impair hand function and thus interfere with activities and social participation. Grip and lateral pinch movements are most affected and have a direct impact on independence, self-care, and leisure activities. This review’s objective is to find physical therapy techniques for patients with thumb CMC OA’ and their effect on pain, function, grip strength, and quality of life. Databases searched were Google Scholar, PubMed, and ScienceDirect with keywords CMC arthritis, OA, function, and physiotherapy. Articles published in the last 5 years, in the English language, randomized controlled trials, controlled trials, prospective studies, or systemic reviews were included. Duplicate and nonrelevant articles, case reports, and noncontrolled trials were excluded. Thirteen articles were found of which five articles were included. Prefabricated CMC-metacarpophalangeal immobilization splint, proprioceptive exercises, and ischemic compression over myofascial trigger points in the first dorsal interossei, first dorsal interossei strengthening, and a self-management program called OA thumb-based therapy trial has shown an effect on pain, pinch strength, grip strength, and quality of life. Additional treatments can be used along with conservative treatment for better results in reducing pain, improving grip strength, function, and quality of life in patients with CMC joint arthritis. Utilizing these methods can enhance clinical practice interventions in the management of thumb CMC joint arthritis.

Drama Therapy for Children and Adolescents with Psychosocial Problems: A Systemic Review on Effects, Means, Therapeutic Attitude, and Supposed Mechanisms of Change.

Drama therapy is applied to children and adolescents with psychosocial problems. Drama therapy is an experimental form of treatment which methodologically uses drama and theatre processes to achieve psychological growth. Although in clinical practice, drama therapy has been applied successfully, little is known about how and why drama therapy contributes to a decrease in psychosocial problems. A systematic narrative review was performed to obtain more insight into this issue. Eight databases were systematically searched. Ten out of 3742 studies were included, of which there were four random controlled trails, three non-controlled trials, and three pre-and post-test design studies. We identified the results, drama therapeutic means, attitude, and mechanism of change. Positive effects were found on overall psychosocial problems, internalizing and externalizing problems, social functioning, coping and regulation processes, social identity, and cognitive development. An adaptive approach was mentioned as the therapeutic attitude. The means established contribute to a dramatic reality, which triggers the mechanisms of change. These are processes that arise during treatment and which facilitate therapeutic change. We found ten supposed mechanisms of change to be frequently used in all studies. No direct relations were found between the results, drama therapeutic attitude, means, and mechanisms of change.

Cost per Event Averted in Cancer Trials in the Adjuvant Setting From 2018 to 2022

Adjuvant therapies are often approved based on improvements in disease-, progression-, or relapse-free survival (ie, an event). An important estimate in adjuvant therapies is the cost per event averted. To characterize the costs per event averted of anticancer drugs approved by the US Food and Drug Administration (FDA) between January 2018 and March 2022. In this cross-sectional study, all approvals were reviewed from the FDA website. Approvals selected for the analysis needed to be drawn from randomized trials involving anticancer drugs studied in the adjuvant treatment of solid tumors. Treatments of nonsolid tumors; nonrandomized, noncontrolled trials; and unpublished trials were excluded. Approvals between January 2018 and March 2022 were included, and 11 trials met inclusion criteria. The monthly costs of each agent were abstracted from the Micromedex RED BOOK database. All variables included in calculations were derived from the original trial publication. Information abstracted for each approval included the name of the drug approved, name of the trial, primary end point, dosing regimen in the trial, median duration of treatment, tumor type, monthly costs per drug, and the number needed to treat for the primary end point. Data were analyzed in March 2022. The cost per event averted for each agent studied in each clinical trial; the monthly cost of each drug, the cost per patient for each drug, the primary clinical end point studied in each trial; the study's design and setting. A total of 11 approvals were included in the study. From January 2018 to March 2022, all approvals were based on a surrogate end point as the primary end point, with no trials demonstrating, to date, an overall survival benefit. The median cost per event averted of drugs in the adjuvant setting was $1 610 000 (range, $820 000 to $2 640 000). The median cost of a complete adjuvant treatment was $158 000 per patient. In this cross-sectional study, anticancer agents in the adjuvant setting were approved based on disease-, progression-, event-, or relapse-free survival. Costs per event averted were high. These findings suggest that these drugs may not achieve wide or global use unless their efficacy improves or their prices decrease.

Autonomic Dysreflexia following Spinal Cord Injury.

Autonomic dysreflexia (AD) is a potentially life-threatening condition of the autonomic nervous system following spinal cord injury at or above T6. One of the most common symptoms is a sudden increase in blood pressure induced by afferent sensory stimulation owing to unmodulated reflex sympathetic hyperactivity. Such episodes of high blood pressure might be associated with a high risk of cerebral or retinal hemorrhage, seizures, heart failure, or pulmonary edema. In-depth knowledge is, therefore, crucial for the proper management of the AD, especially for spine surgeons, who encounter these patients quite often in their clinical practice. Systematical review of the literature dealing with strategies to prevent and manage this challenging condition was done by two independent reviewers. Studies that failed to assess primary (prevention, treatment strategies and management) and secondary outcomes (clinical symptomatology, presentation) were excluded. A bibliographical search revealed 85 eligible studies that provide a variety of preventive and treatment measures for the subjects affected by AD. As these measures are predominantly based on noncontrolled trials, long-term prospectively controlled multicenter studies are warranted to validate these preventive and therapeutic proposals.

The role of keratinized mucosa width as a risk factor for peri-implant disease: A systematic review, meta-analysis, and trial sequential analysis.

BackgroundStudies have examined the benefit of having keratinized peri‐implant mucosa width with mixed results.PurposeThis study examines whether the lack of a prespecified (2 mm) amount of keratinized mucosa width (KMW) is a risk factor for peri‐implant diseases.MethodsA systematic electronic and manual search of randomized or nonrandomized controlled or noncontrolled clinical trials was conducted. Qualitative review, quantitative meta‐analysis, and trial sequence analysis (TSA) of implants inserted at sites with <2 mm or ≥2 mm of KMW were analyzed to compare all the predetermined outcome variables. The level of evidence concerning the role of KMW in peri‐implant health was evaluated via the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) system guide.ResultsNine studies were included in the qualitative analysis and four in the meta‐analysis and TSA. No significant inter‐group difference (p > 0.05) and a low power of evidence were found for probing depth, soft‐tissue recession, and marginal bone loss. A significant difference favoring ≥2 mm KMW had a lower mean plaque index (MD = 0.37, 95% CI: [0.16, 0.58], p = 0.002) (3 studies, 430 implants, low‐quality evidence). GRADE system showed very low and low quality of evidence for all other outcome measures.ConclusionBased on the available studies, the impact of amount of KMW (either <2 mm or ≥ 2 mm) as a risk factor for developing peri‐implant disease remains low. Future control studies with proper sample size and longer follow‐up are needed to further validate current findings.

Effects of community health worker-based interventions on physical activity levels in children: a systematic review.

ABSTRACTObjective: To identify the strategies and effects of interventions carried out by community health workers (CHW) on physical activity (PA) levels in children and adolescents.Data source: In August 2020, a systematic review, designed according to the PRISMA checklist items, was conducted by searches in seven electronic databases and in reference lists. Original studies were searched without restriction with regard to year of publication; they were written in Spanish, English or Portuguese and examined interventions implemented by CHW, involving theoretical and/or practical contents of PA, with a focus on children and/or adolescents between three and 19 years of age.Data synthesis: Of the 2,321 studies initially retrieved, eight were included, targeting samples with more specific characteristics (e.g., clinical, ethnic and/or socioeconomic). In all studies, CHW were trained to lead educational activities. In three non-controlled trials, positive results were observed, involving indicators such as moderate and vigorous PA and physical inactivity reduction. Also, two positive results were found in reducing sedentary behavior.Conclusions: Even though most of the interventions included did not have a significant effect on increasing PA levels, the available findings reinforce the role of CHW as an important strategy for dialogue between health services and the most vulnerable communities, and they suggest a greater articulation of these professionals in the actions developed in the school context.

Use of Patient-Reported Outcome Measures and Patient-Reported Experience Measures Within Evaluation Studies of Telemedicine Applications: Systematic Review.

BackgroundWith the rise of digital health technologies and telemedicine, the need for evidence-based evaluation is growing. Patient-reported outcome measures (PROMs) and patient-reported experience measures (PREMs) are recommended as an essential part of the evaluation of telemedicine. For the first time, a systematic review has been conducted to investigate the use of PROMs and PREMs in the evaluation studies of telemedicine covering all application types and medical purposes.ObjectiveThis study investigates the following research questions: in which scenarios are PROMs and PREMs collected for evaluation purposes, which PROM and PREM outcome domains have been covered and how often, which outcome measurement instruments have been used and how often, does the selection and quantity of PROMs and PREMs differ between study types and application types, and has the use of PROMs and PREMs changed over time.MethodsWe conducted a systematic literature search of the MEDLINE and Embase databases and included studies published from inception until April 2, 2020. We included studies evaluating telemedicine with patients as the main users; these studies reported PROMs and PREMs within randomized controlled trials, controlled trials, noncontrolled trials, and feasibility trials in English and German.ResultsOf the identified 2671 studies, 303 (11.34%) were included; of the 303 studies, 67 (22.1%) were feasibility studies, 70 (23.1%) were noncontrolled trials, 20 (6.6%) were controlled trials, and 146 (48.2%) were randomized controlled trials. Health-related quality of life (n=310; mean 1.02, SD 1.05), emotional function (n=244; mean 0.81, SD 1.18), and adherence (n=103; mean 0.34, SD 0.53) were the most frequently assessed outcome domains. Self-developed PROMs were used in 21.4% (65/303) of the studies, and self-developed PREMs were used in 22.3% (68/303). PROMs (n=884) were assessed more frequently than PREMs (n=234). As the evidence level of the studies increased, the number of PROMs also increased (τ=−0.45), and the number of PREMs decreased (τ=0.35). Since 2000, not only has the number of studies using PROMs and PREMs increased, but the level of evidence and the number of outcome measurement instruments used have also increased, with the number of PREMs permanently remaining at a lower level.ConclusionsThere have been increasingly more studies, particularly high-evidence studies, which use PROMs and PREMs to evaluate telemedicine. PROMs have been used more frequently than PREMs. With the increasing maturity stage of telemedicine applications and higher evidence level, the use of PROMs increased in line with the recommendations of evaluation guidelines. Health-related quality of life and emotional function were measured in almost all the studies. Simultaneously, health literacy as a precondition for using the application adequately, alongside proper training and guidance, has rarely been reported. Further efforts should be pursued to standardize PROM and PREM collection in evaluation studies of telemedicine.

Endovenous Laser Ablation, Radiofrequency Ablation and Flebogrif versus Conventional Surgery in Treatment of Primary Varicose Vein of the Lower Limb: Prospective Randomized Controlled Study

Background: Endovenous laser ablation (EVLA), radiofrequency ablation (RFA) and mechanochemical ablation (MOCA) of primary varicose vein are thought to minimise postoperative morbidity and reduce work loss compared with the conventional surgical procedure. Objective: To determine, whether endovenous ablation methods (radiofrequency, laser and mechanochemical) have any advantages or disadvantages in comparison with conventional surgery, in the treatment of primary varicose vein. Patients and Methods: This was a prospective randomized study,conductedonforty patients presented at Vascular Outpatient Clinic for management of chronic venous insufficiency. All patients underwent clinical examination and duplex ultrasonography. Ten (10) patients were treated with ligation and stripping of the great saphenous vein (GSV). Ten (10) patients were treated with radiofrequency ablation. Ten (10) patients were treated with endovenous laser ablation. Ten (10) patients were treated with Flebogrif. Results: Compared with conventional surgery, endovenous ablation methods reduced postoperative discomfort and pain, with a lower complication rate after treatment for avoidance of a groin incision and dissection at the saphenofemoral confluence. Cosmetic demands were also better satisfied. Non-controlled clinical trials have shown that the ablation rate of GSV after EVLA is over 90%. However, risks of EVLA, RFA and Flebogrif remain in terms of recanalization and neoreflux via junctional tributaries. Conclusion: RFA, EVLA, and Flebogrif are minimally invasive procedures. Their potential early benefits, by avoiding groin dissection and GSV stripping, have been confirmed by the findings from this trial. Current evidence based on randomized trials consistently demonstrates significant early benefits after RFA, EVLA and Flebogrif in suitable patients with varicose veins.